Transcutaneous Autonomic Modulation in Thoracic Surgery

Not Applicable

Terminated

• Conditions: Postoperative Complications; Atrial Fibrillation, Postoperative; Inflammation
• Interventions: Device: Sham LLVNS; Device: Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS)

• Registration Number: NCT02783157
• Lead Sponsor: Duke University

Brief Summary

In this study, the investigators aim to determine whether non-invasive autonomic modulation decreases inflammation and complications after thoracic surgery. The investigators will test the hypothesis that low-level transcutaneous vagal nerve stimulation (LLVNS) during major thoracic surgery reduces inflammation and complications, particularly postoperative atrial fibrillation (POAF). This will be a prospective randomized pilot trial of 200 patients undergoing major thoracic surgery including lobectomy, bilobectomy, or pneumonectomy via either video-assisted thoracoscopic (VAT) or open thoracotomy. Patients will be randomized to receive ether a) LLVNS (n=100) or b) sham LLVNS (n=100) during their procedure. All patients will receive standardized anesthetic, surgical, and post-surgical care. The primary outcome in this study will be time to occurrence of in-hospital POAF, which will be compared between groups using Cox proportional hazards models. Secondary outcomes will be ICU and hospital length of stay, postoperative morbidity, postoperative mortality, and serologic markers of inflammation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-13
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-26
• Primary Completion: 2020-02-21
• Study Completion: 2020-02-21
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Major thoracic surgery (lobectomy, bilobectomy, or pneumonectomy via either video-assisted thoracoscopic (VAT) or open thoracotomy)

Exclusion Criteria

• Patients >90 or <40 years of age
• Chronic atrial fibrillation
• Prior splenectomy
• Preoperative inotropic support
• Hepatic or renal failure
• Currently receiving vagal nerve stimulation therapy
• Taking centrally-acting cholinergic medications (tacrine, donepezil, rivastigmine)
• High-grade atrioventricular block (>2nd degree atrioventricular blockade)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham LLVNS	Sham LLVNS	n=100 patients will be randomized to sham LLVNS, with the clip applied but no stimulation delivered.
Transcutaneous low-level vagal nerve stimulation (LLVNS)	Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS)	n=100 patients will be randomized to transcutaneous low-level vagal nerve stimulation (LLVNS), via a clip applied to the ear. Stimulation will be delivered throughout the procedure.

Primary Outcome Measures

Name	Time	Method
Incidence/Burden of Postoperative Atrial Fibrillation	Inpatient hospitalization approximately 3 to 7 days

Secondary Outcome Measures

Name	Time	Method
Serologic Markers of Inflammation	Inpatient hospitalization approximately 3 to 7 days	Cytokine levels, measured in pg/mL
Postoperative mortality	Inpatient hospitalization approximately 3 to 7 days, and one year after surgery	The incidence of complications during the index hospitalization and one year after surgery
Postoperative morbidity	Inpatient hospitalization approximately 3 to 7 days, and one year after surgery	The incidence of complications during the index hospitalization and one year after surgery

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States